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Backgrounders/Fact Sheets

St. Francis Heart Center surgeon Marc Gerdisch, M.D.,  has successfully performed the first-ever surgeries to repair or remodel heart structures, such as valves, using a unique bio-scaffold “patch” that enables patients to naturally re-grow their own cardiovascular tissue. Known as the Extracellular Matrix, this revolutionary bio-material harnesses the body’s innate ability to repair damaged heart tissue.

Nearly 20,000 implants of CorMatrix ECM™ occurred since the first product was launched in 2006. Preclinical and clinical studies continue to look at new ways the unique CorMatrix ECM may advance the future of cardiovascular medicine. Future clinical studies will support further understanding of the value of CorMatrix ECM in addressing cardiovascular disease.

Surgeries performed using this unique procedure
Dr. Gerdisch has performed a nearly 40 surgeries using the ECM for valve repair and remodeling since 2007.

  • In August 2007, Dr. Gerdisch became the first in the world to apply this technology inside the heart, repairing a congenital heart defect.
  • In February 2008, he used the ECM for the first-ever enlargement of the path that blood follows as it exits the heart in lieu of a synthetic patch or animal tissue
  • In September 2008, he performed the first-ever ECM mitral valve reconstruction using matrix to replace damage tissue.
  • The ECM has been used successfully since 2006 to repair the pericardium, the protective "sac" surrounding the heart, following open heart surgery.

How ECM works
The cells in our bodies can only grow and multiply if they have some type of structure to which they can attach. This structural “bio-scaffold” within our bodies supports and encourages cell growth, which ultimately forms different types of tissue. The ECM serves as that bio-scaffold for some patients requiring complex valve repair or replacement surgery.

Once the ECM “patch” is surgically implanted, the patient’s own cells migrate and integrate into the bio-scaffold, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation. During the tissue repair process, the matrix is degraded and reabsorbed, leaving remodeled functional tissue.

Why Dr. Gerdisch uses ECM
Once surgically implanted, the ECM serves as a bio-scaffold into which the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanism to repair tissue at the site of implantation.

Animal tissue implants are subject to calcium deposition and hardening, because of the body’s ability to recognize them as foreign. Synthetic material lacks the performance characteristics of tissue and causes an inflammatory response by the body. ECM, however, leads to the growth of new, functional tissue.

How ECM is made
The ECM is derived from the small intestine of a pig and is processed in a way that removes all cells, leaving the complex structural matrix – made of collagen – intact.

Impact of valve disease and this procedure
Each year, millions of people are diagnosed with valve disease or a valve disorder. Valve disease occurs when the heart’s valves do not work correctly, causing the heart muscle to have to work harder to circulate the right amount of blood through the body. Valve disease can be caused by either stenosis or regurgitation:

Stenosis occurs when the valve(s) opening becomes narrowed or valves become damaged or scarred, inhibiting the flow of blood out of the heart’s ventricles or atria (the chambers of the heart). This restriction requires the heart to pump harder, which can strain the heart and reduce blood flow to the body.

Regurgitation, or a “leaky valve,” occurs when leaflets on the heart valves do not close completely, letting blood move backward through the valve.

Surgery to repair or replace the valve(s) has proven to be the most effective way to treat this life-threatening disease. Using ECM for valve repair and remodeling allows not only for the patient’s valve to be repaired, but also enables the patient to re-grow his or her own cardiovascular tissue..

Marc Gerdisch, M.D.
Marc Gerdisch, M.D. is the director of cardiothoracic surgery at the St. Francis Heart Center located at St. Francis Hospital & Health Centers in Indianapolis, Ind. He is also the co-director of the St. Francis Heart Valve Center. Dr. Gerdisch has specialized in complex heart valve surgeries for much of his surgical career.

St. Francis Heart Center
The St. Francis Heart Center is dedicated to providing patients with the region's most comprehensive heart and vascular services. The commitment of our physicians to the prevention and cure of heart disease has led to innovative care, better outcomes and improved quality of life for patients. St. Francis created the Emergency Heart Attack Response Team protocol, which has revolutionized heart attack treatment in the United States and abroad. St. Francis has the only 24/7 comprehensive heart center in south central Indiana, providing everything from open heart surgery to valve repair.

About CorMatrix® ECM Technology™
CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring ECM™ products for cardiovascular applications. The company currently has U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure, and clearance in the U.S. for use in cardiac tissue repair.